The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

851–875 of 2235

  • HighFDA (Devices)·Z-1983-2018·2018-06-06

    Arrow International Recalls MAC Two-Lumen Central Venous Access Kits

    Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2018·2018-06-06

    Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise

    Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00376-SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk

    Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2018·2018-06-06

    Arrow PSI Kit Recall Due to Potential Sterility Compromise

    Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling Sterile Needle Counters because packaging seal creep may compromise sterility. The recall covers 38,464 units distributed in the US, Canada, and other countries.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2018·2018-06-06

    Medline Needle Counters Recalled Due to Packaging Seal Creep

    Medline Industries Inc is recalling MEDLINE O.R. Necessities Sterile Needle Counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2018·2018-06-06

    Arrow PICC Sets Recalled Due to Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised product sterility.

    Product
    ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2018·2018-06-06

    Arrow International Recalls Maximal Barrier Drapes Due to Packaging Defect

    Arrow International is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall covers lots distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Code: ASK-01000-UPMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2018·2018-06-06

    Arrow Central Venous Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2018·2018-06-06

    Arrow International Recalls Clear Fenestrated Drapes Due to Packaging Issues

    Arrow International Inc is recalling 416,055 Clear Fenestrated Drapes with Adhesive because unsealed packaging may compromise product sterility.

    Product
    Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Unsealed Packaging

    Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00001-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 7Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2018·2018-06-06

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Sterility Concerns

    Arrow International Inc is recalling VPS Rhythm ECG Accessory Packs because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 35 other countries.

    Product
    VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
    Category
    Medical Device
    Distribution
    Distributed nationwide